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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05840133
Other study ID # YXLL-KY-2023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2027

Study information

Verified date April 2023
Source Qianfoshan Hospital
Contact Chunqing Wang, Dr.
Phone 053189269680
Email 1150156766@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators will detect the expression of HBV-related HCC biomarker lncRNA SNHG15 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.


Description:

Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and lncRNA SNHG15 was detected by RT-PCR. At the same time, healthy subjects were selected as the control group, and lncRNA SNHG15 in blood was detected by RT-PCR. At the same time, the correlation between lncRNA SNHG15 and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 156
Est. completion date December 31, 2027
Est. primary completion date January 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - The age and sex of the healthy control group were matched with that of HBV-associated patient group. There was no tumor in the other parts of the body, and no tumor in the blood system. The healthy control group did not have any liver benign diseases. There are no inflammatory diseases in other parts of the body; the functions of the liver, kidney, and heart were normal. Exclusion Criteria: - The volunteer has tumors in the liver or other parts of the body, or blood system tumors; The volunteer has benign liver diseases; The patient has inflammatory disease elsewhere. If the volunteer has any one of the above diseases, it shall be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

References & Publications (7)

Befeler AS, Di Bisceglie AM. Hepatocellular carcinoma: diagnosis and treatment. Gastroenterology. 2002 May;122(6):1609-19. doi: 10.1053/gast.2002.33411. — View Citation

Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review. Ann Intern Med. 2017 May 2;166(9):637-648. doi: 10.7326/M16-2575. Epub 2017 Mar 21. — View Citation

Johnson PJ. The role of serum alpha-fetoprotein estimation in the diagnosis and management of hepatocellular carcinoma. Clin Liver Dis. 2001 Feb;5(1):145-59. doi: 10.1016/s1089-3261(05)70158-6. — View Citation

Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403. doi: 10.1016/S2468-1253(18)30056-6. Epub 2018 Mar 27. — View Citation

Prevention of Infection Related Cancer (PIRCA) Group, Specialized Committee of Cancer Prevention and Control, Chinese Preventive Medicine Association; Non-communicable & Chronic Disease Control and Prevention Society, Chinese Preventive Medicine Association; Health Communication Society, Chinese Preventive Medicine Association. [Strategies of primary prevention of liver cancer in China: expert consensus (2018)]. Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Jan 6;53(1):36-44. doi: 10.3760/cma.j.issn.0253-3766.2018.07.013. Chinese. — View Citation

Sartorius K, Sartorius B, Aldous C, Govender PS, Madiba TE. Global and country underestimation of hepatocellular carcinoma (HCC) in 2012 and its implications. Cancer Epidemiol. 2015 Jun;39(3):284-90. doi: 10.1016/j.canep.2015.04.006. Epub 2015 Apr 25. — View Citation

Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of lncRNA SNHG15 in HBV-associated HCC patients before surgery The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method. 1 to 3 days before surgery
Secondary Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 week after surgery The expressions of lncRNA SNHG15 in tissues: In the tumor and adjacent tissues from HBV-associated HCC patients, the expressions of lncRNA SNHG15were measured by real-time fluorescence quantitative PCR method.
The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
one week after surgery
Secondary Detection of lncRNA SNHG15 in HBV-associated HCC patients at 6 months after surgery The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method. 6 months postoperatively
Secondary Detection of lncRNA SNHG15 in the control groups as baseline The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method. the level of lncRNA SNHG15 were detected as baseline
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